Accuray Precision Treatment Planning System

Basic Information

• Brand Name: Accuray Precision Treatment Planning System
• Primary DI: 00811376030146
• Version / Model: 1070891
• Catalog Number: NA
• Company Name: Accuray Incorporated
• Labeler DUNS: 080044624
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-27
• Public Version: 2
• Public Version Date: 2021-06-28
• Public Version Status: Update
• Public Device Record Key: df195cad-8987-4c64-a0f1-2b67b760a8e7

Device Description

Accuray Precision™ Treatment Planning System (Version 3.1)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MUJ	System, Planning, Radiation Therapy Treatment	Radiology	892.5050	2
IYE	Accelerator, Linear, Medical	Radiology	892.5050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40941	Radiation therapy treatment planning workstation	A freestanding image processing device that is a component of radiation therapy treatment planning configuration. It is sometimes considered to be a component of a picture archiving and communication system (PACS) or a local area network (LAN) configuration, e.g., a radiology information system (RIS) or hospital information system (HIS). It does not contain any controls for the direct operation of a radiation therapy system. It can receive and transmit data both on-line and off-line and is configured to provide the capability to remotely process, manipulate and view patient images and information used in treatment planning, record and verification.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811376030146	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K171086	000